Effects of Remote Ischemic Pre-Conditioning in Moyamoya Disease Patients

Beijing Tiantan Hospital328 enrolled

Overview

In the present study, investigators evaluated whether RIPC reduce the major neurological complications in adult moyamoya disease patients undergoing encephaloduroarteriosynangiosis (EDAS).

BACKGROUND: Brain ischemia and injury contributed to perioperative morbidity and mortality in revascularization surgery. Remote ischemic preconditioning (RIPC), brief periods of ischemia followed by reperfusion, can provide systemic protection for prolonged ischemia. Previous study found combined remote ischemic pre- and post-conditioning can be effective in reducing neurologic complications and the duration of hospitalization in moyamoya patients undergoing direct revascularization.In order to investigate whether RIPC before EDAS can protect these patients from the perioperative and long-term complications, a prospective randomized controlled trial will be performed in the current study. DESIGNING: About 328 patients who are eligible for carotid artery stenting will be randomly assigned in 1:1 ratio to RIPC group and sham RIPC group (control). Remote limb ischemic preconditioning (RIPC) is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, it is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min, patients in the RIPC group will do it twice a day for at least five days before EDAS. Patients in the sham RIPC group receive sham RIPC treatment, which is consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min, they will do it twice a day for at least five days before EDAS. Cerebral injury is assessed by plasma Human Soluble protein-100B (S-100B) and Neuron specific enolase (NSE). Clinical outcomes are determined by cerebrovascular events (including ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and transient neurological deficit) and death or dependent.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

328

Conditions

Moyamoya Disease Remote Ischemic Preconditioning

Interventions

Remote ischemic preconditioningPROCEDURE

Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.

Sham remote ischemic preconditioningPROCEDURE

Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.

EncephaloduroarteriosynangiosisPROCEDURE

Encephaloduroarteriosynangiosis is an indirect revascularization surgery of moyamoya disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who diagnosed with moyamoya disease 2. Adults 18 to 65 years of age 3. The onset symptoms manifested as ischemic symptoms (TIA or stroke) or atypical symptoms (headache, epilepsy or asymptomatic) 4. Able to receive the necessary imaging examination 5. Patients who pre-agreed to the study Exclusion Criteria: 1. Prior cerebral hemorrhage history 2. Other brain or cerebrovascular disease 3. Previous history of revascularization surgery 4. Dependent (mRS \> 2) 5. Receive other type of revascularization surgery 6. Peripheral blood vessel disease (especially subclavian arterial and upper limb artery stenosis or occlusion). 7. Patients who do not agree with the study

Locations (2)

Beijing Tiantan Hosiptal

Beijing, Beijing Municipality, China

Peking University International Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Number of Patients With Cerebrovascular Events.

Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome.

Time frame: postoperative one month

Number of Patients Dependent or Death

Dependent included the modified Rankin Scale (mRS) \> 2. Death included any reason caused death.

Time frame: postoperative one month

Secondary Outcomes

The Severity of the Ischemic Stroke after Surgery

The severity of the ischemic stroke was evaluated by the white matter hyperintensities volume on the MRI, the neurological deficits duration and the Modified Rankin Scale (mRS) of patients.

Time frame: postoperative one month

Number of Patients Occured Re-stroke at Follow-up Period

Re-stroke included ischemic stroke and hemorrhagic stroke.

Time frame: 6 months and 12 months after EDAS

Number of Patients Dependent or Death at Follow-up Period

Dependent included the modified Rankin Scale (mRS) \> 2. Death included any reason caused death.

Time frame: 6 months and 12 months after EDAS

Number of Patients with Improved Neurological Function at Follow-up Period

The modified Rankin Scale (mRS) decreased at the follow-up period compared to preoperative scores

Time frame: 6 months and 12 months after EDAS

Perfusion Status of Patients at Follow-up Period

The perfusion status detected by stages of pre-infarction period based on computed tomography perfusion imaging

Data from ClinicalTrials.gov

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